- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00879515
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Genetics and Physiology of Social Anxiety in Fragile X
Studieoversikt
Status
Detaljert beskrivelse
Anxiety is a common and significant problem for people suffering from disorders of nervous system development, including fragile X syndrome. There are few validated treatments for anxiety in people with these disorders, in part because the biological basis of anxiety in neurodevelopmental disorders has not been clearly described. This study will evaluate the physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X premutation (a mild version of the genes that cause fragile X syndrome) to a variety of sensory, emotional, and social stimuli. By analyzing the data collected for this study, researchers aim to identify physiological characteristics linked to subgroups within the disorders, demonstrate links between physiological responses and behavioral or psychiatric symptoms, and measure physiological changes in people receiving treatment for their disorders.
Participation in this study will include one testing session, which will take between 3 and 3.5 hours. Participants who receive treatment for their anxiety may be asked to complete this testing a second time, after their treatment. During the testing session, sensors will be placed on participants' skin in several locations to measure heart rate, sweat response, and eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds, lights, smells, pictures that elicit different types of emotions, an interaction with an unfamiliar person, and specialized toys. In addition, participants will undergo blood testing and have several samples of their saliva collected on the day of the testing session. Participants will also be asked to collect additional saliva samples at home three times a day on 4 different days. Child participants and their parents may also be asked to complete questionnaires and interviews about behavioral and emotional problems.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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California
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Sacramento, California, Forente stater, 95817
- M.I.N.D. Institute, University of California, Davis
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Fragile X premutation or fragile X syndrome, measured by DNA testing; Down syndrome, confirmed by chromosomal analysis; or normally developing control
- Normal hearing
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
1
Males and females with fragile X syndrome, ages 5 to 25 years old
|
|
2
Males and females with the FMR1 premutation, ages 5 to 25 year old
|
|
3
Males and females with Down syndrome, ages 5 to 25 years old
|
|
4
Males and females with normal development, ages 5 to 25 years old
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fear-potentiated startle reflex
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Nevroatferdsmanifestasjoner
- Medfødte abnormiteter
- Genetiske sykdommer, medfødte
- Intellektuell funksjonshemming
- Nevroutviklingsforstyrrelser
- Barneutviklingsforstyrrelser, gjennomgripende
- Abnormiteter, flere
- Kromosomforstyrrelser
- Sykdom
- Angstlidelser
- Autismespektrumforstyrrelse
- Downs syndrom
- Utviklingshemning
Andre studie-ID-numre
- 200210645
- DDTR B2-MBA (Annet stipend/finansieringsnummer: National Institute of Mental Health)
- K23MH077554 (U.S. NIH-stipend/kontrakt)
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